Steering your processes towards good data quality
Amongst the many challenges that the healthcare industry faces, complexities in study design and data collection are extending the time taken to prepare clinical data for regulatory submissions. This will increase the cost for sponsor companies and there is also the risk that data is misinterpreted either during submission preparation or by the regulatory agencies. The standardization of clinical data helps companies understand their clinical data effectively and is helping regulatory agencies streamline their review times.
The implementation of CDISC Data Standards within an organization can be a complex operation as many stakeholders need to be consulted and operational procedures considered. When the implementation is complete, reductions in submission time, savings in resource costs as well as increases in quality will happen immediately.
As with any asset of the organization, the definition of effective governance is necessary to obtain maximum value.
To answer this matter, BDLS has created a strong expertise & various accelerators in the Data Governance landscape, based on a range of tools and process to plan, supervise and control over data management and its use.